Recruiting

DBS

Sponsor:

University Health Network, Toronto

Code:

NCT05699330

Conditions

Frontotemporal Dementia

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Bilateral subgenual cingulate deep brain stimulation (SGC DBS)

Study Details

Brief summary:

Frontotemporal dementia (FTD), the most common dementia in individuals younger than 60 years of age, has no disease-modifying treatment. Neuroimaging studies have revealed salience and default mode network dysfunction, frontotemporal atrophy and hypometabolism as pathophysiological hallmarks of behavioral variant FTD (bvFTD). A key brain structure affected by bvFTD is the subgenual cingulate (SGC), which serves as a hub for multi-axonal projections to and from the ventromedial prefrontal, dorsal anterior cingulate, orbitofrontal, and dorsolateral frontal cortices, and limbic structures.

The disruption of these SGC projections in bvFTD result in the core clinical features of apathy, disinhibition, loss of empathy, compulsivity, hyperorality and loss of executive function. The central goal of this proposal is to use deep brain stimulation (DBS) for modulation of the SGC downstream projections to treat bvFTD. Investigators hypothesize that SGC DBS will drive activity in the dysfunctional networks, reverse hypometabolism, and potentially improve symptoms. To determine the physiologic effects and mechanisms of SGC DBS, investigators will assess cerebral metabolism by FDG-PET, connectivity by rsfMRI and MEG, atrophy by volumetric MRI, and neurodegenerative and neuroinflammatory biomarkers. The safety and preliminary efficacy data obtained in these patients will inform the possible future role of DBS in apathetic bvFTD.

Conditions

Frontotemporal Dementia

Deep Brain Stimulation

Study ID

NCT05699330

Start date

Jan 12, 2023

Status verified date

May, 2023

Completion date

Jan 12, 2026

Anticipated

Primary completion date

Jan 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men and women aged 40-85 years
2. Diagnosis of image-supported behavioral variant frontotemporal dementia according to NIC-FTD and NACC FTLD guidelines
3. Apathy as one of the symptoms
4. Stable dose of baseline FTD medications for at least 3 months
5. The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function. The patient must also have a substitute decision maker, if different from caregiver, to sign the informed consent for participation in the study.

Exclusion Criteria:

1. Meets diagnostic criteria for other psychiatric diagnosis
2. Has other major Central Nervous System (CNS) disease that impairs motor, sensory or cognitive
3. Alcohol or illegal substance dependence within last 12 months
4. Other medical conditions which render anesthesia and surgery as unsafe as determined by neurosurgeon
5. Contraindications for MRI scanning, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
6. Has a medical condition requiring a repetitive MRI body scan
7. Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous (immunosuppressive or) steroid therapy
8. Is unable to comply with study visit schedule and timeline
9. Past significant intracranial surgery
10. A female lactating or of child-bearing potential, with a positive pregnancy test or not using adequate contraception.

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bilateral subgenual cingulate deep brain stimulation (SGC DBS)

Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone. All patients will receive deep brain stimulation (DBS) targeting the subgenual cingulate (SGC) bilaterally. No other changes to pre-existing treatment will be made. This is the only arm in this experiment.

Interventions

Bilateral subgenual cingulate deep brain stimulation (SGC DBS)

Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone. All patients will receive deep brain stimulation (DBS) targeting the subgenual cingulate (SGC) bilaterally. No other changes to pre-existing treatment will be made. This is the only arm in this experiment.

Primary outcome measure

  • Incidence of Treatment-related Adverse Events [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Cletus Cheyuo, MD, PhD

6478076845cletus.cheyuo@uhn.ca

Tasnuva Hoque

416-603-5800tasnuva.hoque@uhnresearch.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Cletus Cheyuo

6478076845cletus.cheyuo@uhn.ca

Tasnuva Hoque

4166035800tasnuva.hoque@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 10, 2023

Last verified

May, 2023

Keywords

  • Subgenual cingulate
  • Deep brain stimulation
  • Apathy
  • Behavioral variant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-05-10.